1. Field of the Invention
The present invention relates generally to the disposal of controlled substances such as medication. Specifically, this invention relates to a method, system, and apparatus for the collection of excess controlled substances (wastage), analysis of the wastage, and documentation of the wastage. Further, this invention relates to a method for collecting, analyzing, and documenting the wastage, as well as reconciling the documentation.
2. Description of Related Art
A controlled substance is a drug or drug product that comes under the jurisdiction of the federal Controlled Substances Act of 1970 and is distributed and used in accordance with the Comprehensive Drug Abuse Prevention and Control Act of 1971. A narcotic, depressant, stimulant, hallucinogenic or anabolic steroid drug that is covered by the Controlled Substances Act (CSA) is obtained in a variety of ways by licensed facilities, pharmacies, or caregivers:                The drug is dispensed by the manufacturer or pharmaceutical supplier directly to the facility (i.e. hospital, laboratory, or patient care facility) or pharmacy.        A pharmacy directly dispenses the drug in a unit dose or as part of a drug pack, which may include varying amounts of controlled drugs.        A pharmacy may dispense these drugs through an automated drug dispensing system such as systems manufactured by Omnicell® (Palo Alto, Calif.) or Pyxis® (San Diego, Calif.). U.S. Pat. Nos. 5,797,515, 5,713,485, 6,068,156, 6,011,999, 5,927,540, 5,905,653, 5,805,456, 5,745,366, 6,151,536, 5,431,299, 6,116,461, 6,021,392, 6,003,006, 5,842,976, 5,014,875, and 4,785,969 disclose medication dispensing systems, methods, and devices.        
Once the drug is obtained it is utilized in the prescribed manner either administered to a patient, utilized as part of an infusion, or utilized in a laboratory study. Frequently, there is an excess of the drug that must be disposed of in a controlled manner regulated by enforcement agencies such as the DEA, State Boards of Pharmacy, and state and local law enforcement agencies. Failure to adhere to their regulations can bring stiff penalties such as fines, imprisonment, and loss of license to handle and dispense controlled substances. Because of this, it is imperative for anyone involved in the use of controlled substances to strictly follow these regulations.
Policies of regulatory agencies and also patient care facilities dictate that any excess drug be disposed and rendered useless for human consumption. Also, the process of wasting these drugs must be a witnessed event. This requires the witness to visually observe the amount or volume of drug wasted and which drug is being wasted. The witness then confirms this by signature. The wastage witness signature is recorded either in handwritten form or on a computerized system (such as the case with Omnicell® or Pyxis® systems previously mentioned).
There are several serious shortcomings of the current disposal system and method:                Firstly, all injectable controlled substances are currently manufactured as clear liquids, meaning their appearance is the same as saline or even water. This creates the potential for easily substituting any other clear liquid for the controlled substance. The potential for theft of these drugs for self-medication or illicit sale remains high even with the strictest enforcement.        To document the wastage, the person wasting the controlled substance must find another person to witness the waste process and verify the process by way of a signature. In most facilities, this requires the signature of a person with an advanced clinical degree such as a Registered Nurse or an authorized clinician. During busy times this process may be delayed or forgotten.        The disposal process (“wasting”) is also imperfect. Typically the controlled substance is disposed by injection into a sink, expelled onto the floor, or dropped into a needle disposal container. In the case of partially used vials of controlled substances, these are sometimes deposited intact into needle disposal containers and could potentially be retrieved for unauthorized or illicit use.        Once the controlled substance is wasted, the process must be documented. Documentation consists of recording information such as the patient's name, the name of the controlled substance and its concentration, and the quantity (e.g., volume) that is wasted. Frequently, the records are handwritten and therefore prone to the pitfalls of poor handwriting and illegibility during review. Other times, the records are generated through computerized dispensing system units such as Onmicell® or Pyxis®. These systems require both the person wasting the substance and the witness to log on and complete several screen commands to complete the process.        Once the documentation is complete, the record of the administration (i.e., the patient's record) must match that of the wastage process. This is a labor-intensive task that requires a pharmacy's staff to spend hours reviewing records and reconciling discrepancies that arise during reviews.        
All steps in the current method are time consuming and laborious with potential for fraud. In addition, there is not a routine provision for verifying the actual composition and concentration of the wasted substance and no efficient means for disseminating the information surrounding the process. It is therefore desirable to have a method for accurately monitoring and documenting the disposal of controlled substances. Further, it is desirable to have an automated system and apparatus for collecting excess and unwanted controlled substances, rendering the controlled substances unusable for human consumption, documenting information about the collection and disposal of the controlled substances, and reconciling the information with other information systems.